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This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke. The purpose of the study is to evaluate the clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Phase 1 consisted of 5 unblinded subjects receiving nTVNS to assess device usability and safety. Phase 2 used a Prospective Randomized Open, Blinded Endpoint (PROBE) design comparing nTVNS to sham stimulation in 11 subjects. The study will inform the design and implementation of a pivotal study.
This pilot study proceeded in two phases: Phase I, an unblinded stage, and Phase II, a blinded stage comparing intervention and sham groups.
Phase I consisted of 5 subjects, unblinded, receiving nTVNS. This phase tested the usability of the device and de-risked the use of nTVNS during rehabilitation. Visits included consent and baseline evaluation, followed by 6 weeks of treatment consisting of upper extremity rehabilitation paired with nTVNS. Rehabilitation and treatment occurred at a cadence of 3 sessions per week. Primary endpoints was collected after 6 weeks.
Phase II consisted of a Prospective Randomized Open, Blinded Endpoint (PROBE) design with 11 subjects randomized to an intervention nTVNS group or a control sham stimulation group. Both groups received a stimulation tolerability assessment at the start of each session to support blinding for therapists and subjects. For the sham group, no stimulation was delivered during the priming or rehabilitation portions of the session. The same evaluations, sessions, and endpoints occurred as those in Phase 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paired nTVNS Stimulation | Experimental | Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions. |
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| Sham Stimulation | Sham Comparator | For the active sham comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. Following the tolerability assessment, the device delivers 0 mA stimulation during the priming period and rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) | Device | Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change | The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). | Within 7 days of completing 6 weeks of rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) Average Change | The ARAT will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The ARAT is a widely used clinical scoring tool for stroke rehabilitation. The test consists of 19 items that are grouped into four sub-tests: grasp, grip, pinch, and gross movement. The total score on the ARAT ranges from 0 to 57, with a higher score indicating better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Communicative Effectiveness Index (CETI) Score | The Communicative Effectiveness Index (CETI) is a rating scale that measures change in functional communication in adults with aphasia. It assesses functionality across 16 communication situations rated by someone who interacts with the subject. The CETI score will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. Collected for subjects with aphasia only. |
Inclusion Criteria:
Exclusion Criteria
Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
Participant has a fever or shows clinical signs concerning for an infectious disease
Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
Low heart rate (<60 bpm) from a cardiac conduction block or related etiology
Participant has a history of trigeminal neuralgia
Participant has a history of Bell's Palsy
History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
History of recurrent syncopal events
Known or newly-discovered aneurysm or arteriovenous malformation
Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
Botox injections 12 weeks prior to or during therapy
Participants who have had a craniectomy:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Savitz, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Kirt Gill, MD | NeuraStasis, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| Upper Limb Rehabilitation | Other | Rehabilitation movements to improve upper limb function after stroke |
|
| Sham Stimulation | Other | Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation. |
|
| Within 7 days of completing 6 weeks of rehabilitation |
| Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response % | The FMA-UE will be analyzed for the % of subjects that responded to treatment defined as achieving an effect equivalent to a greater than the minimal clinically important difference. | Within 7 days of completing 6 weeks of rehabilitation |
| Proportion of subjects completing all pre-specified treatment doses | Proportion of subjects completing all pre-specified treatment sessions across the 6 weeks of rehabilitation | Upon completion of 6 weeks of rehabilitation |
| Subject Questionnaire on Device Usage | A questionnaire that evaluates subjects' level of comfort during use of the device on a 5-point scale, with 5 being the most comfortable and 1 being the least comfortable. | Upon completion of 6 weeks of rehabilitation |
| Therapist Questionnaire on Device Usage | A questionnaire that evaluates the ease of use of the device by therapists during the administration of rehab with the device on a 5-point scale, with 5 being the most usable and 1 being the least usable. | Upon completion of 6 weeks of rehabilitation |
| Serious adverse device effects (SADE) rate at 24 hours post-therapy session | SADE rate at 24 hours post-therapy sessions | Up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation |
| Stroke impact scale (SIS) Domain and Summative Score Average Change | The Stroke Impact Scale (SIS) is a multidimensional self-reported measure of health-related quality of life. The SIS includes 59 items and assesses 8 domains: strength (four items), memory and thinking (seven items), emotion (nine items), communication (seven items), activities of daily living (ten items), mobility (nine items), hand function (five items) and participation and function in life activities (ten items). Each item is rated using a 5-point Likert-type scale (1 = an inability to complete the item; 5 = no difficulty experienced at all) and a global score is calculated as a summative score of each domain, transformed into a 0-100 scale. It includes an extra question on the person´s perceived stroke recovery measured in the form of a visual analogue scale from 0-100. Individual domain scores and the summative score will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. | Within 7 days of completing 6 weeks of rehabilitation |
| Analysis of the number of stimulations per therapy session | The number of paired stimulations initiated each rehabilitation session will be analyzed to understand personalized effectiveness and responder likelihood. | Collected at each therapy session across 6 weeks of rehabilitation |
| Within 7 days of completing 6 weeks of rehabilitation |
| ID | Term |
|---|---|
| D010291 | Paresis |
| D020521 | Stroke |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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